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2.
Spinal Cord ; 57(5): 348-359, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30962518

RESUMEN

STUDY DESIGN: Narrative review by individuals experienced in the recruitment of participants to neurotherapeutic clinical trials in spinal cord injury (SCI). OBJECTIVES: To identify key problems of recruitment and explore potential approaches to overcoming them. METHODS: Published quantitative experience with recruitment of large-scale, experimental neurotherapeutic clinical studies targeting central nervous system and using primary outcome assessments validated for SCI over the last 3 decades was summarized. Based on this experience, potential approaches to improving recruitment were elicited from the authors. RESULTS: The rate of recruitment has varied between studies, depending on protocol design and other factors, but particularly inclusion/exclusion criteria. The recruitment rate also ranged over an order of magnitude between individual centers in a given study. In older multicenter studies, average recruitment rate was approximately one person per study center per month. More recent trials experienced lower rates of recruitment and potential reasons for this trend were examined. The current roles and potential of various stakeholder organizations in addressing problems of recruitment were explored. In addition, recent developments in methodology may help reduce the number of subjects required for well-powered studies. CONCLUSIONS: Several approaches are emerging to improve clinical trial design, efficacy outcome measures, and quantifiable surrogate markers, all of which should reduce the number of participants required for adequate statistical power. There is a growing sense of cooperation between various stakeholders but more should be done to bring together consumer and provider groups to improve recruitment and the effectiveness and relevance of neurotherapeutic clinical trials.


Asunto(s)
Ensayos Clínicos como Asunto/métodos , Selección de Paciente , Traumatismos de la Médula Espinal/epidemiología , Traumatismos de la Médula Espinal/terapia , Humanos , Traumatismos de la Médula Espinal/diagnóstico
3.
J Spinal Cord Med ; 41(2): 216-222, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-28417673

RESUMEN

CONTEXT/OBJECTIVE: To describe current and future directions in spinal cord injury (SCI) research. DESIGN: The SCI Model Systems (SCIMS) programs funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) during the 2011 to 2016 cycle provided abstracts describing findings from current research projects. Discussion among session participants generated ideas for research opportunities. SETTING/PARTICIPANTS: Pre-conference workshop before the 2016 American Spinal Injury Association (ASIA) annual meeting. A steering committee selected by the SCIMS directors that included the moderators of the sessions at the ASIA pre-conference workshop, researchers presenting abstracts during the session, and the audience of over 100 attending participants in the pre-conference workshop. METHODS/RESULTS: Group discussion followed presentations in 5 thematic areas of (1) Demographics and Measurement; (2) Functional Training; (3) Psychosocial Considerations; (4) Assistive Technology; and (5) Secondary Conditions. The steering committee reviewed and summarized discussion points on future directions for research and made recommendations for research based on the discussion in each of the five areas. CONCLUSION: Significant areas in need of research in SCI remain, the goal of which is continued improvement in the quality of life of individuals with SCI.


Asunto(s)
Investigación Biomédica/tendencias , Dispositivos de Autoayuda/tendencias , Traumatismos de la Médula Espinal/rehabilitación , Investigación Biomédica/métodos , Humanos , Calidad de Vida
4.
Spinal Cord ; 56(5): 414-425, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29284795

RESUMEN

STUDY DESIGN: This is a focused review article. OBJECTIVES: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified. METHODS: The methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review. RESULTS: COAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered. CONCLUSIONS: With an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA. SPONSORS: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.


Asunto(s)
Ensayos Clínicos como Asunto/métodos , Evaluación de Resultado en la Atención de Salud/métodos , Traumatismos de la Médula Espinal/diagnóstico , Traumatismos de la Médula Espinal/terapia , Humanos
5.
Spinal Cord ; 56(2): 126-132, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29105658

RESUMEN

STUDY DESIGN: Secondary analysis of prospectively collected observational data. OBJECTIVES: To assess the representativeness of the Spinal Cord Injury Model Systems National Database (SCIMS-NDB) of all adults aged 18 years or older receiving inpatient rehabilitation in the United States (US) for new onset traumatic spinal cord injury (TSCI). SETTING: Inpatient rehabilitation centers in the US. METHODS: We compared demographic, functional status, and injury characteristics (nine categorical variables comprising of 46 categories and two continuous variables) between the SCIMS-NDB (N = 5969) and UDS-PRO/eRehabData (N = 99,142) cases discharged from inpatient rehabilitation in 2000-2010. RESULTS: There are negligible differences (<5%) between SCIMS-NDB patients and the population for 31 of the 48 comparisons. Minor differences (5-10%) exist for age categories, sex, race/ethnicity, marital status, FIM Motor score, and time from injury to rehabilitation admission. Important differences (>10%) exist in mean age and preinjury occupational status; the SCIMS-NDB sample was younger and included a higher percentage of individuals who were employed (62.7 vs. 41.7%) and fewer who were retired (10.2 vs. 36.1%). CONCLUSIONS: Adults in the SCIMS-NDB are largely representative of the population of adults receiving inpatient rehabilitation for new onset TSCI in the US. However, users of the SCIMS-NDB may need to adjust statistically for differences in age and preinjury occupational status to improve generalizability of findings.


Asunto(s)
Bases de Datos Factuales/estadística & datos numéricos , Traumatismos de la Médula Espinal/epidemiología , Traumatismos de la Médula Espinal/rehabilitación , Adolescente , Adulto , Distribución por Edad , Factores de Edad , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Pacientes Internos , Masculino , Persona de Mediana Edad , Centros de Rehabilitación/estadística & datos numéricos , Estados Unidos , Adulto Joven
6.
Arch Phys Med Rehabil ; 97(10): 1647-55, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26971670

RESUMEN

OBJECTIVE: To assess the patterns of sacral sparing and recovery in newly injured persons with traumatic spinal cord injury (SCI). DESIGN: Retrospective analysis of data from the national Spinal Cord Injury Model Systems (SCIMS) database for patients enrolled from January 2011 to February 2015. SETTING: SCIMS centers. PARTICIPANTS: Individuals (N=1738; age ≥16y) with traumatic SCI admitted to rehabilitation within 30 days after injury with follow-up at discharge, at 1 year, or both. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: International Standards for Neurological Classification of Spinal Cord Injury examination results at admission and follow-up (discharge or 1y, or both). RESULTS: Conversion from an initial American Spinal Injury Association Impairment Scale (AIS) grade A to incomplete status was 20% at rehabilitation discharge and 27.8% at 1 year, and was greater in cervical and low paraplegia levels (T10 and below) than in high paraplegia level injuries (T1-9). Conversion from AIS B to motor incomplete was 33.9% at discharge and 53.6% at 1 year, and the initial sparing of all sacral sensory components was correlated with the greatest conversion to motor incomplete status at discharge and at 1 year. For patients with initial AIS C, the presence of voluntary anal contraction (VAC) in association with other sacral sparing was most frequently observed to improve to AIS D status at discharge. However, the presence of VAC alone as the initial sacral sparing component had the poorest prognosis for recovery to AIS D status. At follow-up, regaining sacral sparing components correlated with improvement in conversion for patients with initial AIS B and C. CONCLUSIONS: The components of initial and follow-up sacral sparing indicated differential patterns of neurologic outcome in persons with traumatic SCI. The more sacral components initially spared, the greater the potential for recovery; and the more sacral components gained, the greater the chance of motor recovery. Consideration of whether VAC should remain a diagnostic criterion sufficient for motor incomplete classification in the absence of other qualifying sublesional motor sparing is recommended.


Asunto(s)
Modalidades de Fisioterapia , Sacro/fisiopatología , Traumatismos de la Médula Espinal/clasificación , Traumatismos de la Médula Espinal/rehabilitación , Índices de Gravedad del Trauma , Adolescente , Adulto , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paraplejía/rehabilitación , Pronóstico , Recuperación de la Función , Estudios Retrospectivos , Traumatismos de la Médula Espinal/fisiopatología , Adulto Joven
8.
Neurorehabil Neural Repair ; 29(9): 867-77, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25644238

RESUMEN

BACKGROUND: Several novel drug- and cell-based potential therapies for spinal cord injury (SCI) have either been applied or will be considered for future clinical trials. Limitations on the number of eligible patients require trials be undertaken in a highly efficient and effective manner. However, this is particularly challenging when people living with incomplete SCI (iSCI) represent a very heterogeneous population in terms of recovery patterns and can improve spontaneously over the first year after injury. OBJECTIVE: The current study addresses 2 requirements for designing SCI trials: first, enrollment of as many eligible participants as possible; second, refined stratification of participants into homogeneous cohorts from a heterogeneous iSCI population. METHODS: This is a retrospective, longitudinal analysis of prospectively collected SCI data from the European Multicenter study about Spinal Cord Injury (EMSCI). We applied conditional inference trees to provide a prediction-based stratification algorithm that could be used to generate decision rules for the appropriate inclusion of iSCI participants to a trial. RESULTS: Based on baseline clinical assessments and a defined subsequent clinical endpoint, conditional inference trees partitioned iSCI participants into more homogeneous groups with regard to the illustrative endpoint, upper extremity motor score. Assuming a continuous endpoint, the conditional inference tree was validated both internally as well as externally, providing stable and generalizable results. CONCLUSION: The application of conditional inference trees is feasible for iSCI participants and provides easily implementable, prediction-based decision rules for inclusion and stratification. This algorithm could be utilized to model various trial endpoints and outcome thresholds.


Asunto(s)
Ensayos Clínicos como Asunto , Proyectos de Investigación , Traumatismos de la Médula Espinal/terapia , Algoritmos , Médula Cervical/lesiones , Determinación de Punto Final , Humanos , Estudios Longitudinales , Enfermedades del Sistema Nervioso/terapia , Estudios Prospectivos , Estudios Retrospectivos
9.
Top Spinal Cord Inj Rehabil ; 18(1): 1-14, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-23239927

RESUMEN

Effective treatment after cervical spinal cord injury (SCI) is imperative as so many activities of daily living (ADLs) are dependent on functional recovery of arm and hand actions. We focus on defining and comparing neurological and functional endpoints that might be used during acute or subacute Phase 2 clinical trials involving subjects with cervical sensorimotor complete SCI (ASIA Impairment Scale [AIS-A]). For the purposes of this review, the trial would examine the effects of a pharmaceutical small molecule, drug, biologic, or cell transplant on spinal tissue. Thus, neurological improvement is the intended consequence and is most directly measured by assessing neurological impairment (eg, motor aspects of the International Standards Neurological Classification of Spinal Cord Injury [ISNCSCI]). However, changes in neurological function, even if statistically significant, may not be associated with a clear functional impact (ie, a meaningful improvement in individual activity, such as independent self-care ADLs). The challenge is to measure improvement as precisely as possible (change in impairment), but to define a clinically meaningful response in the context of functional improvement (impact on activity limitations). The principal comparisons focused on elements of the ISNCSCI assessment, including upper extremity motor score and motor level. Personal activity capabilities were also examined at various time points. The data suggest that an improvement of 2 or more motor levels after cervical sensorimotor complete SCI may be a clinically meaningful endpoint threshold that could be used for acute and subacute Phase 2 trials with subjects having sensorimotor complete cervical SCI.

10.
Neurorehabil Neural Repair ; 26(9): 1064-71, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22647878

RESUMEN

BACKGROUND: For therapeutics directed to the injured spinal cord, a change in neurological impairment has been proposed as a relevant acute clinical study end point. However, changes in neurological function, even if statistically significant, may not be associated with a functional impact, such as a meaningful improvement in items within the self-care subscore of the Spinal Cord Independence Measure (SCIM). OBJECTIVE: The authors examined the functional significance associated with spontaneously recovering upper-extremity motor function after sensorimotor-complete cervical spinal cord injury (SCI). METHODS: Using the European Multi-center Study about Spinal Cord Injury (EMSCI) data set, a retrospective analysis was undertaken of individuals with cervical sensorimotor-complete SCI (initial motor level, C4-C7). Specifically, changes in upper-extremity motor score (UEMS), motor level, and SCIM (total and self-care subscore) were assessed between approximately 1 and 48 weeks after injury (n = 74). RESULTS: The initial motor level did not significantly influence the total UEMS recovered or number of motor levels recovered. SCIM self-care subscore recovery was significantly greater for those individuals regaining 2 motor levels compared with those recovering only 1 or no motor levels. However, the recovery in the SCIM self-care subscore was not significantly different between individuals recovering only 1 motor level and those individuals who showed no motor-level improvement. CONCLUSIONS: A 2 motor-level improvement indicates a clinically meaningful change and might be considered a primary outcome in acute and subacute interventional trials enrolling individuals with cervical sensorimotor-complete SCI.


Asunto(s)
Vida Independiente , Movimiento/fisiología , Recuperación de la Función , Traumatismos de la Médula Espinal/rehabilitación , Actividades Cotidianas , Adulto , Vértebras Cervicales/lesiones , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Autocuidado , Sensación/fisiología , Resultado del Tratamiento , Extremidad Superior/fisiopatología
11.
Spine J ; 12(5): 389-400.e3, 2012 May.
Artículo en Inglés | MEDLINE | ID: mdl-22572584

RESUMEN

BACKGROUND CONTEXT: Sensory and/or motor function sparing, including the S4-S5 spinal cord segment, is central to classifying neurologic impairment after spinal cord injury (SCI) using the American Spinal Injury Association Impairment Scale (AIS) grades within the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Within the ISNCSCI protocol, which is essential for both clinical and research purposes, assessing sacral sparing requires an anorectal and S4-S5 examination. However, in situations where these data are incomplete, the relationships between anorectal/S4-S5 examinations and functional preservation at more rostral sacral segments may be useful. PURPOSE: To evaluate whether slightly more rostral sensory and motor outcomes of the ISNCSCI can accurately predict caudal sacral sparing (S4-S5 dermatome sensation, "deep pressure" anal sensation [AS], and voluntary anal contraction [AC]). STUDY DESIGN: Retrospective analysis of the European Multicenter Study about Spinal Cord Injury database. PATIENT SAMPLE: One thousand four hundred sixty-seven AIS-A, AIS-B, and AIS-C subjects. OUTCOME MEASURES: International Standards for Neurological Classification of Spinal Cord Injury examinations. METHODS: The value of six factors (sensory preservation at S1, S2, and S3; motor preservation at S1; motor function at more than three segments below the motor level; and sensory function at more than three segments below the neurologic level) for predicting ISNCSCI sacral sparing measures (AS, S4-S5 dermatome sensation, AC) was evaluated. Combinations of the most promising factors were then evaluated for their ability to accurately predict the AIS grade. RESULTS: Preserved sensation at the first sacral segment (S1S) provided good prediction (90.5%) of caudal sacral sensory sparing (ie, AS or S4-S5 sensation). Voluntary anal contraction was accurately predicted by preserved motor function within the first sacral segment (S1M) in 85.4% of cases. The alternate classification schemes evaluated for accurately predicting the AIS classification grade were S1S+S1M and S1S+motor preservation more than three segments below the motor level. The ability of these schemes to accurately predict AIS grades was stable over time but varied with the rostrocaudal level of spinal injury. For the initial baseline examination, the alternate classification schemes were accurate in ~95% of cases for T2-T9 SCI, with slightly lower accuracy for cervical SCI (~80%). CONCLUSIONS: There are close relationships between functional sparing at different sacral segments. These relationships can be used to estimate AIS grades when complete information about the anorectal and S4-S5 examination is not available. The accuracy of the classification remains stable over time, while the increased variability in lower levels of SCI, that is, lumbar injuries, emphasizes the importance of careful sacral examinations. The highly reliable predictive values of S1-S3 segments can complement conclusions from anorectal examinations if the latter are considered to be confounded or incomplete.


Asunto(s)
Examen Físico , Sacro/fisiopatología , Traumatismos de la Médula Espinal/clasificación , Traumatismos de la Médula Espinal/diagnóstico , Canal Anal/inervación , Humanos , Actividad Motora/fisiología , Estudios Retrospectivos , Sensación/fisiología
12.
Am J Phys Med Rehabil ; 91(1): 80-93, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21681060

RESUMEN

Population aging, caused by reductions in fertility and increasing longevity, varies by country and is anticipated to continue and to reach global proportions during the 21st century. Although the effects of population aging have been well documented for decades, the impact of aging on people with spinal cord injury (SCI) has not received similar attention. It is reasonable to expect that population aging features such as the increasing mean age of the population, share of the population in the oldest age groups, and life expectancy would be reflected in SCI population demographics. Although the mean age and share of the SCI population older than 65 yrs are increasing, data from the National Spinal Cord Injury Statistical Center suggest that life expectancy increases in the SCI population have not kept the same pace as those without SCI in the last 15 yrs. The reasons for this disparity are likely multifactorial and include the changing demographics of the SCI population with more older people being injured; susceptibility of people with SCI to numerous medical conditions that impart a health hazard; risky behaviors leading to a disproportionate percentage of deaths as a result of preventable causes, including septicemia; changes in the delivery of health services during the first year after injury when the greatest resources are available; and other unknown factors. The purposes of this paper are (1) to define and differentiate general population aging and aging in people with SCI, (2) to briefly present the state of the science on health conditions in those aging with SCI, and finally, (3) to present recommendations for future research in the area of aging with SCI.


Asunto(s)
Envejecimiento/fisiología , Continuidad de la Atención al Paciente/organización & administración , Personas con Discapacidad/rehabilitación , Guías de Práctica Clínica como Asunto , Traumatismos de la Médula Espinal/rehabilitación , Adulto , Anciano , Investigación Biomédica , Femenino , Predicción , Humanos , Puntaje de Gravedad del Traumatismo , Cuidados a Largo Plazo , Masculino , Persona de Mediana Edad , Evaluación de Necesidades , Paraplejía/diagnóstico , Paraplejía/rehabilitación , Cuadriplejía/diagnóstico , Cuadriplejía/rehabilitación , Traumatismos de la Médula Espinal/cirugía , Estados Unidos , Adulto Joven
14.
Arch Phys Med Rehabil ; 92(3): 361-8, 2011 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21353820

RESUMEN

OBJECTIVE: To examine the amount and type of therapy services received in inpatient and postdischarge settings during the first year after spinal cord injury (SCI). DESIGN: Prospective observational longitudinal cohort design. Data were obtained from systematic recording of interventions by clinicians and from patient interview. SETTING: Inpatient and postdischarge rehabilitation programs. PARTICIPANTS: Patients (N=493) with traumatic SCI admitted to 6 rehabilitation centers participating in the SCIRehab study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Hours of therapy by physical therapy (PT), occupational therapy (OT), speech therapy, recreation therapy, psychology, social work/case management, and nursing education during initial inpatient rehabilitation and postdischarge up to the first anniversary of injury. Inpatient data were collected prospectively by the treating clinicians; postdischarge service data were collected by patient self-report during follow-up interviews. RESULTS: Of the total hours spent on these rehabilitation interventions during the first year after injury, 44% occurred after discharge from inpatient rehabilitation. Participants received 56% of their PT hours after discharge and 52% of their OT hours, but only a minority received any postdischarge services from other rehabilitation disciplines. While wide variation was found in the total hours of inpatient treatment across all disciplines, the variation in the total hours of postdischarge services was greater, with the interquartile range of postdischarge services being twice that of the inpatient services. CONCLUSIONS: SCI rehabilitation is often given in a care continuum, with inpatient rehabilitation being only the beginning. Reductions in inpatient SCI rehabilitation length of stay are well documented, but the postdischarge services that may replace some inpatient treatment appear to be greater than previously reported. The availability and impact of postdischarge care should be studied in greater detail to capture the wide array of postdischarge services and outcomes.


Asunto(s)
Pacientes Internos/estadística & datos numéricos , Pacientes Ambulatorios/estadística & datos numéricos , Traumatismos de la Médula Espinal/rehabilitación , Adulto , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Tiempo , Índices de Gravedad del Trauma
15.
Arch Phys Med Rehabil ; 92(3): 369-75, 2011 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21353821

RESUMEN

OBJECTIVE: To present upper- (UEMS) and lower-extremity motor score (LEMS) recovery, American Spinal Injury Association Impairment Scale (AIS) change, and motor level change in persons with traumatic tetraplegia from the Spinal Cord Injury Model Systems (SCIMS). DESIGN: Longitudinal cohort; follow-up to 1 year. SETTING: U.S. SCIMS. PARTICIPANTS: Subjects (N=1436; age>15y) with tetraplegia with at least 2 examinations, the first within 7 days of injury. Subjects were 80% men injured by vehicular collisions (44%), falls (30%), sports (12%), and violence (11%). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Change in AIS, UEMS, LEMS, and motor levels. RESULTS: From a baseline of 7 days or less, 22% of subjects with AIS grade A converted to AIS grade B or better by rehabilitation discharge; and 30%, by 1 year, with 8% to AIS grade C and 7.1% to grade D. Conversion from complete to motor incomplete was not related to timing of the initial examination (P=.54) or initial neurologic level (P=.96). For AIS grade B, 34% remained motor complete, 30% became AIS grade C, and 37% became grade D by 1 year. Although 82.5% of those with AIS grade C improved to AIS grades D and E, mean 1-year UEMS score was only 35 points. UEMS scores in patients with AIS grade A increased a mean of 9 to 11 points, except for C1 to C3 and C8 to T1 motor levels (gain, 2-3 points). Motor level was unchanged or ascended in 35% and improved 1 level in 42%, 2 levels in 14%, and more than 2 levels in 9%. Motor zone of partial preservation of 2 segments or more was associated with gain of 2 or more motor levels, with a relative risk of 5.0 (95% confidence interval, 3.2-7.8; P<.001). CONCLUSIONS: More patients with cervical complete spinal cord injury may be converting to AIS grade D compared with earlier reports. Motor level recovery in those with AIS grade A and UEMS recovery in those with AIS grade C injuries are potential outcomes for acute clinical trials.


Asunto(s)
Vértebras Cervicales , Extremidad Inferior , Recuperación de la Función , Traumatismos de la Médula Espinal/rehabilitación , Extremidad Superior , Adolescente , Adulto , Niño , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Cuadriplejía/etiología , Factores Socioeconómicos , Traumatismos de la Médula Espinal/complicaciones , Adulto Joven
16.
Arch Phys Med Rehabil ; 92(3): 376-83, 2011 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21353822

RESUMEN

OBJECTIVE: To determine the effect of sensory sparing in motor complete persons with spinal cord injury (SCI) on completion of rehabilitation on neurologic, functional, and social outcomes reported at 1 year. DESIGN: Secondary analysis of longitudinal data collected by using prospective survey-based methods. SETTING: Data submitted to the National SCI Statistical Center Database. PARTICIPANTS: Of persons (N=4106) enrolled in the model system with a motor complete injury (American Spinal Injury Association Impairment Scale [AIS] grade A or B) at the time of discharge between 1997 and 2007, a total of 2331 (56.8%) completed a 1-year follow-up interview (Form II) and 1284 (31.3%) had complete data for neurologic (eg, AIS grade, injury level) variables at 1 year. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: AIS grade (A vs B) at 1 year, bladder management, hospitalizations, perceived health status, motor FIM items, Satisfaction With Life Scale, depressive symptoms, and social participation. RESULTS: Compared with persons with AIS grade A at discharge, persons with AIS grade B were less likely to require indwelling catheterization and be hospitalized and more likely to perceive better health, report greater functional independence (ie, self-care, sphincter control, mobility, locomotion), and report social participation in the first year postinjury. A greater portion of individuals with AIS grade B at discharge had improved neurologic recovery at 1 year postinjury than those with AIS grade A. Significant AIS group differences in 1-year outcomes related to physical health were maintained after excluding persons who improved to motor incomplete status for only bladder management and change in perceived health status. This recognition of differences between persons with motor complete injuries (AIS grade A vs B) has important ramifications for the field of SCI rehabilitation and research.


Asunto(s)
Sacro , Traumatismos de la Médula Espinal/rehabilitación , Actividades Cotidianas , Adulto , Evaluación de la Discapacidad , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Factores Socioeconómicos , Índices de Gravedad del Trauma
17.
Arch Phys Med Rehabil ; 92(3): 457-63, 2011 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-21353827

RESUMEN

OBJECTIVE: To examine differences in perceived quality of life (QOL) at 1 year postinjury between people with tetraplegia who required mechanical ventilation assistance at discharge from rehabilitation and those who did not. DESIGN: Prospective cross-sectional examination of people with spinal cord injury (SCI) drawn from the SCI Model Systems National Database. SETTING: Community. PARTICIPANTS: People with tetraplegia (N=1635) who sustained traumatic SCI between January 1, 1994, and September 30, 2008, who completed a 1-year follow-up interview, including 79 people who required at least some use of a ventilator at discharge from rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Satisfaction With Life Scale (SWLS); Craig Handicap Assessment and Reporting Technique (CHART)-Short Form Physical Independence, Mobility, Social Integration, and Occupation subscales; Patient Health Questionnaire-9 (PHQ-9), Medical Outcomes Study 36-Item Short-Form Health Survey self-perceived health status. RESULTS: Significant differences were found between the ventilator-user (VU) group and non-ventilator-user (NVU) group for cause of trauma, proportion with complete injury, neurologic impairment level, and number of rehospitalizations. The NVU group had significantly higher SWLS and CHART Social Integration scores than the VU group after controlling for selected covariates. The NVU group also had more positive perceived health status compared with a year previously and a lower incidence of depression assessed by using the PHQ-9 than the VU group. There were no significant differences between groups for perceived current health status. CONCLUSIONS: People in this study who did not require mechanical ventilation at discharge from rehabilitation post-SCI reported generally better health and improved QOL compared with those who required ventilator assistance at 1 year postinjury. Nonetheless, the literature suggests that perceptions of QOL improve as people live in the community for longer periods.


Asunto(s)
Estado de Salud , Cuadriplejía/psicología , Calidad de Vida/psicología , Respiración Artificial/psicología , Traumatismos de la Médula Espinal/psicología , Adulto , Estudios Transversales , Depresión/etiología , Depresión/psicología , Femenino , Humanos , Relaciones Interpersonales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Cuadriplejía/etiología , Cuadriplejía/rehabilitación , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/rehabilitación , Índices de Gravedad del Trauma
18.
J Neurosurg Spine ; 11(4): 445-60, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19929342

RESUMEN

OBJECT: Permanent neurological loss after spinal cord injury (SCI) is a well-known phenomenon. There has also been a growing recognition and improved understanding of the pathophysiological mechanisms of late progressive neurological loss, which may occur after SCI as a result of posttraumatic spinal cord tethering (SCT), myelomalacia, and syringomyelia. A clinical study of 404 patients sustaining traumatic SCIs and undergoing surgery to arrest a progressive myelopathy caused by SCT, with or without progressive myelomalacia and cystic cavitation (syringomyelia) was undertaken. Both objective and subjective long-term outcomes were evaluated. To the authors' knowledge, this is the first series of this size correlating long-term patient perception of outcome with long-term objective outcome analyses. METHODS: During the period from January 1993 to November 2003, 404 patients who had previously sustained traumatic SCIs underwent 468 surgeries for progressive myelopathies attributed to tethering of the spinal cord to the surrounding spinal canal, with or without myelomalacia and syrinx formation. Forty-two patients were excluded because of additional pathological entities that were known to contribute to a progressive myelopathy. All surgeries were performed by the same neurosurgeon at a single SCI treatment center and by using a consistent surgical technique of spinal cord detethering, expansion duraplasty, and when indicated, cyst shunting. RESULTS: Outcome data were collected up to 12 years postoperatively. Comparisons of pre- and postoperative American Spinal Injury Association sensory and motor index scores showed no significant change when only a single surgery was required (86% of patients). An outcome questionnaire and phone interview resulted in > 90% of patients self-assessing arrest of functional loss; > 50% of patients self-assessing improvement of function; 17 and 18% self-assessing improvement of motor and sensory functions to a point greater than that achieved at any time postinjury, respectively; 59% reporting improvement of spasticity; and 77% reporting improvement of hyperhidrosis. CONCLUSIONS: Surgery for spinal cord detethering, expansion duraplasty, and when indicated, cyst shunting, is a successful treatment strategy for arresting a progressive myelopathy related to posttraumatic SCT and syringomyelia. Results suggest that surgery leads to functional return in ~ 50% of patients, and that in some patients posttraumatic SCT limits maximal recovery of spinal cord function postinjury. A patient's perception of surgery's failure to arrest the progressive myelopathy corresponds closely with the need for repeat surgery because of retethering, cyst reexpansion, and pseudomeningocele formation.


Asunto(s)
Defectos del Tubo Neural/cirugía , Procedimientos Neuroquirúrgicos , Traumatismos de la Médula Espinal/cirugía , Siringomielia/cirugía , Adolescente , Adulto , Anciano , Dolor de Espalda , Estudios de Seguimiento , Humanos , Hiperhidrosis , Imagen por Resonancia Magnética , Persona de Mediana Edad , Neuronas Motoras/fisiología , Espasticidad Muscular , Defectos del Tubo Neural/etiología , Defectos del Tubo Neural/patología , Complicaciones Posoperatorias , Reoperación , Células Receptoras Sensoriales/fisiología , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/patología , Encuestas y Cuestionarios , Siringomielia/etiología , Siringomielia/patología , Resultado del Tratamiento , Adulto Joven
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